Mastering SS620 & GPDMDS in Singapore
- ISOGuruSG
- Apr 19
- 4 min read
Updated: Apr 20
SS620 GDPMDS (Singapore Standard 620 — Good Distribution Practice for Medical Devices) is a mandatory certification required by Singapore's Health Sciences Authority (HSA) for any company that imports, stores, or distributes medical devices in Singapore. Without it, you cannot legally obtain a Medical Device Dealer's Licence and cannot bring products to market.
What is SS620 GDPMDS? (The Simple Explanation)
Imagine you're running a company that imports medical devices — say, blood glucose monitors or surgical gloves — into Singapore. You need to make sure those products are stored correctly, transported safely, and tracked thoroughly from the moment they leave the factory to the moment they reach a hospital or clinic.
That's exactly what SS620 GDPMDS is designed to enforce. The full name is Singapore Standard SS 620:2016 — Good Distribution Practice for Medical Devices (GDPMDS). It is a quality management system (QMS) standard developed by SPRING Singapore in collaboration with the Health Sciences Authority (HSA).
Think of it as a rulebook that answers: "How must a medical device distributor manage their warehouse, staff, records, and logistics to guarantee that every device is safe when it reaches the patient?"
What does "Good Distribution Practice" mean?
GDP (Good Distribution Practice) is a globally recognised concept used across pharmaceuticals and medical devices. It means following consistent, documented procedures so that products maintain their quality and safety throughout the entire supply chain — not just at the factory, but during shipping, storage, and delivery too.
Watch: Mastering SS620 & GDPMDS in Singapore
Who Needs SS620 Certification?
You need SS620 GDPMDS certification if your company does any of the following in Singapore:
Imports Medical Devices
Bringing medical devices or IVDs into Singapore from overseas suppliers or manufacturers.
Wholesales Medical Devices
Selling medical devices to hospitals, clinics, retailers, or other businesses in bulk.
Stores Medical Devices
Operating a warehouse or storage facility that holds medical devices before distribution.
Handles or Distributes
Managing logistics, secondary assembly, delivery, or post-market servicing of medical devices..
Important: SS620 certification is mandatory BEFORE you apply for an HSA Medical Device Dealer's Licence. You cannot get the licence without the certificate.
Note: If your company manufactures finished medical devices, you'll instead need an ISO 13485 certificate to apply for a Manufacturer's Licence — SS620 is specifically for distributors and importers.
Key Requirements at a Glance
SS620 covers a broad range of requirements across your entire distribution operation. Here are the most important areas your Quality Management System (QMS) must address:
Documentation Control
All procedures, instructions, and records must be documented, version-controlled, and easy to retrieve during an audit.
Storage Conditions
Premises must meet specific environmental requirements — temperature, humidity, cleanliness — for each type of medical device stored.
Staff Training
All personnel handling medical devices must be trained and that training must be documented and regularly reviewed.
Traceability
You must be able to trace every device from supplier to end customer — essential for recalls and post-market surveillance.
Complaint Handling
A documented system to receive, investigate, and respond to complaints about medical device quality or safety.
Supplier Management
Procedures for evaluating and monitoring third-party suppliers, logistics providers, and outsourced activities.
Already have ISO 9001? Good news — companies certified to ISO 9001 will find they have partially fulfilled SS620 requirements. However, there are important differences, particularly around premises management and post-market surveillance, that you'll need to address before getting certified.
What Happens If You Don't Comply?
Non-compliance with SS620 GDPMDS has serious, immediate consequences for your business:
No Dealer's Licence
You cannot apply for an HSA Medical Device Dealer's Licence, making it illegal to import or wholesale medical devices in Singapore.
Products Held at Customs
Shipments can be stopped at Singapore's border if your company lacks the required licence and certification.
Legal Penalties
Operating without a valid HSA licence is a regulatory offence under Singapore's Health Products Act, with fines and potential prosecution.
Lost Business Opportunities
Hospitals, government agencies, and large buyers will only work with licensed dealers. No licence means no contracts.
Frequently Asked Questions
Achieving ISO certification is just the beginning. To sustain the benefits, you must maintain compliance and continuously improve. Here are some tips:
Do I need SS620 if I only distribute Class A (lowest risk) devices?
If you only distribute non-sterile Class A (lowest risk) medical devices, you generally do not need full SS 620 certification, but you must still comply with Good Distribution Practice (GDPMDS) requirements and submit a declaration of conformity, or a simpler declaration of non-dealing in higher-risk devices
Can I use a template to build my QMS documentation?
ISO standards evolve, so keep informed about changes and update your processes accordingly.
What certification bodies are accredited for SS620 in Singapore?
Certification must be conducted by a body accredited by the Singapore Accreditation Council (SAC). Well-known accredited bodies include TÜV SÜD PSB, SOCOTEC Certification Singapore, and Transpacific Certifications. Always verify current accreditation status on the SAC website before engaging a body.
Is SS620 recognised outside of Singapore?
SS620 is a Singapore-specific standard, but it has gained international attention. Some multinational companies in countries where detailed local guidance is still developing use SS620 as a practical benchmark when strengthening their own medical device distribution practices.
What is the difference between GDPMDS and GMP?
GMP (Good Manufacturing Practice) governs the production of medical devices and medicines. GDPMDS (Good Distribution Practice for Medical Devices) governs what happens after manufacturing — the storage, transport, import, and distribution. A device can be manufactured to GMP standards but still be compromised during distribution if GDPMDS requirements are not followed.
Ready to Start Your SS620 Journey?
Don't let certification complexity delay your market entry. Watch the full video above, then reach out to consultant to get a gap assessment todayay.
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